"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-28

Study Completion Date

2021-07-09

Brief Summary

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This is a non-significant risk, multi-center, randomized, active-controlled study to compare the effectiveness of two digital therapies in the management of fibromyalgia over 12 weeks. The primary endpoint is mean change from baseline to Week 12 in the weekly revised Fibromyalgia Impact Questionnaire (FIQ-R) total score.

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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital Acceptance and Commitment Therapy (ACT)

Group Type ACTIVE_COMPARATOR

Digital ACT

Intervention Type DEVICE

Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.

Digital Symptom Tracker

Group Type ACTIVE_COMPARATOR

Digital Symptom Tracker

Intervention Type DEVICE

Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.

Interventions

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Digital ACT

Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.

Intervention Type DEVICE

Digital Symptom Tracker

Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject is 22 to 75 years of age, inclusive
2. Subject has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM, which requires satisfaction of the following criteria:

1. Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5, OR WPI 4-6 and SS scale score ≥9;
2. Symptoms have been present at a similar level for at least 3 months;
3. Pain must be present in at least 4 out of 5 body regions
3. Subject with ongoing treatments should be on stable therapy for 30 days prior to screening appointment.
4. Subject is capable of reading and understanding English and has provided written informed consent to participate.

Exclusion Criteria

1. Lifetime history of bipolar disorder as assessed by the MINI.
2. Current, untreated, major depressive episode and/or anxiety disorders as assessed by the MINI.
3. Subject has a BDI-II total score \> 25 at either the Screening appointment or Baseline appointment.
4. The subject is at increased risk of suicide on the basis of the investigator's judgment, a response \> 1 to BDI item #9, or the results of the Columbia-Suicide Severity Rating Scale ("C-SSRS") conducted at Screening or Baseline (i.e., any suicidal behavior during the preceding year or C-SSRS Type 3, 4, or 5 suicidal ideation during the preceding year).
5. Subject has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the subject, interfere with the evaluation of the study device's efficacy or safety, or compromise the subject's ability to comply with/complete the study.

Minimum Eligible Age

22 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No